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FDA 510(k), K090325, JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
FDA 510(k), K090325, JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
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510(K) Number: K090325
Device Name: JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
Manufacturer: PATHWAY MEDICAL TECHNOLOGIES, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/09/2009
Decision Date: 03/11/2009
Regulation Medical Specialty: Cardiovascular
Device Name: JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
Manufacturer: PATHWAY MEDICAL TECHNOLOGIES, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/09/2009
Decision Date: 03/11/2009
Regulation Medical Specialty: Cardiovascular
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